Rheumatoid Arthritis Clinical Trial
Official title:
Clinical Study Evaluating the Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis
Evaluating the effect of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis
Status | Recruiting |
Enrollment | 80 |
Est. completion date | September 2025 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients with mild to moderate disease activity. - Patient age must be more than 18 years. Exclusion Criteria: - Pregnant and lactating females. - Patients with liver, renal impairment or any other inflammatory diseases. - Patients on TNF-a or IL-1ß antagonists. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria university hospital | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti inflammatory Effect | Measure the change in serum level of IL-1ß at baseline and after treatment in both groups | 3 months | |
Primary | Effect on disease activity | Measure the change in the disease activity at baseline and after 3 months of therapy for each patient in both groups using Disease Activity Score-CRP (DAS28-CRP) which is calculated by a computer based formula consists of several variables: number of swollen joints (0-28), number of tender joints (0-28) and C reactive protein (CRP) (mg/l).
A DAS28 value of >5.1 indicates high disease activity, DAS28 ranged from 3.3 to 5.1 indicates moderate disease activity and DAS28 =3.2 indicates low disease activity. |
3 months | |
Secondary | Hepatoprotective Effect | Measure the change in serum level of Liver enzymes (ALT & AST) at baseline and after treatment in both groups. | 3 months |
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